First-Line Chemotherapy With or Without Neuromuscular Electrical Stimulation in Treating Patients With Non-Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as carboplatin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy can lead to a loss of leg muscle strength. Neuromuscular electrical stimulation may improve muscle strength and quality of life. It is not yet known whether chemotherapy given together with neuromuscular electrical stimulation is more effective than chemotherapy alone in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying first-line chemotherapy given together with neuromuscular electrical stimulation to see how well it works compared with chemotherapy alone in treating patients with non-small cell lung cancer.

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Detailed Description

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OBJECTIVES:

Primary

* To determine the feasibility of first-line palliative chemotherapy alone versus palliative chemotherapy in combination with neuromuscular electrical stimulation (NMES) in patients with non-small cell lung cancer.

Secondary

* To determine if NMES is safe for patients undergoing palliative chemotherapy.
* To determine to what extent 3 or 4 courses of palliative chemotherapy impact leg muscle strength, body composition, and physical activity levels and if the use of NMES influence these changes.
* To determine the rate of recovery or decline in leg muscle strength, body composition, and physical activity levels following completion of 3 or 4 courses of palliative chemotherapy and if the use of NMES influences these changes.
* To assess patient attitudes to the use of NMES during palliative chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I (control): Patients receive first-line palliative chemotherapy comprising carboplatin and vinorelbine in weeks 1, 4, 7, and 10 as part of usual care at Nottingham University Hospital National Health Service Trust.
* Arm II (experimental): Patients receive chemotherapy as in arm I. Patients also undergo, at home, neuromuscular electrical stimulation (NMES) in weeks 2-12 (to the anterior thighs) 3 times a week for 30 minutes. NMES treatment increases in duration on a weekly basis from 11% to 18% to 25%, and then remaining constant thereafter.

All patients undergo assessment of quadriceps muscle strength, body composition, physical activity level, nutritional intake, and fatigue at baseline and week 9, and week 17 or 20. Patients complete quality-of-life questionnaires (EORTC-C30 and LC-13) at baseline, at week 9, and at week 17 or 20.

After completion of study treatment, patients are followed up for 8 weeks.

Conditions

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Chemotherapeutic Agent Toxicity Fatigue Lung Cancer Musculoskeletal Complications

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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carboplatin

Intervention Type DRUG

vinorelbine tartrate

Intervention Type DRUG

neuromuscular electrical stimulation

Intervention Type OTHER

physiologic testing

Intervention Type OTHER

fatigue assessment and management

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed non-small cell lung cancer
* Scheduled to receive 3 or 4 courses of first-line palliative chemotherapy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 3 months
* Not pregnant or nursing
* Able to use neuromuscular electrical stimulation device
* No implanted cardiac pacemaker
* No epilepsy
* No spinal cord pathology

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No